510(k) · Cleared
ClearedPivit a/B ST and Pivit a/B ST-R
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyrx, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Mar 26, 2010 as substantially equivalent to K053656 (Tyrx Pharma, Inc., 2006) and 2 other predicates after a 130-day review. Its family tree reaches back 10 generations to 1992. 5 later devices descend from it.
- Decided
- Mar 26, 2010
- Review
- 130 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K921895 (1992). 71 ancestors in all, the oldest K830889 (1983). 5 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations between
- 3 generations backK052830 SportmeshArtimplant AB · 2006
- 2 generations backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- 1 generation backK090271 Hydrocoat MeshPromethean Surgical Devices, Inc. · 2010
- This deviceK093524 Pivit a/B ST and Pivit a/B ST-RTyrx, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK113229 Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK133223 Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK151177 XenMatrix AB Surgical GraftC. R. Bard · 2015
- Descendant · cites it directly · 0 of its ownK211132 ARISTE AB MeshAriste Medical, LLC · 2022
- Descendant · 3 generations on · 0 of its ownK162193 XenMatrix AB Surgical GraftC. R. Bard · 2016
Show all 10 generations
- Root · 10 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 9 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 8 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 7 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 6 generations backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 5 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 4 generations backK042809 CuffpatchOrganogenesis, Inc. · 2004
- 3 generations backK052830 SportmeshArtimplant AB · 2006
- 2 generations backK071887 Sportmesh or Artelon Tissue ReinforcementArtimplant AB · 2007
- 1 generation backK090271 Hydrocoat MeshPromethean Surgical Devices, Inc. · 2010
- This deviceK093524 Pivit a/B ST and Pivit a/B ST-RTyrx, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc. · 2012 · cites it directly3descendants
- K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014 · 2 generations on2descendants
- K151177XenMatrix AB Surgical GraftC. R. Bard · 2015 · 3 generations on1descendant
- K211132ARISTE AB MeshAriste Medical, LLC · 2022 · cites it directly0descendants
- K162193XenMatrix AB Surgical GraftC. R. Bard · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −9 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −8 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −7 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −6 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −5 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −4 | K042809 | Cuffpatch | Organogenesis, Inc. | 2004 | — |
| −3 | K052830 | Sportmesh | Artimplant AB | 2006 | — |
| −2 | K071887 | Sportmesh or Artelon Tissue Reinforcement | Artimplant AB | 2007 | — |
| −1 | K090271 | Hydrocoat Mesh | Promethean Surgical Devices, Inc. | 2010 | — |
| 0 (this device) | K093524 | Pivit a/B ST and Pivit a/B ST-R | Tyrx, Inc. | 2010 | — |
| +1 | K113229 | Ventrio Light Hernia Patch with TRM Antimicrobial Coating | C.R. Bard, Inc. | 2012 | — |
| +2 | K133223 | Xenmatrix AB Surgical Graft | C.R. Bard, Inc. | 2014 | — |
| +3 | K151177 | XenMatrix AB Surgical Graft | C. R. Bard | 2015 | — |
| +1 | K211132 | ARISTE AB Mesh | Ariste Medical, LLC | 2022 | — |
| +3 | K162193 | XenMatrix AB Surgical Graft | C. R. Bard | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 8 | 0 |
| 2000 | 11 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 7 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053656 | Tyrx Antimicrobial MeshSummary page 1…Device Trade/Proprietary Name: PrVIT A/B ST Device Common/Classification Name: Polymeric Surgical Mesh Predicate Devices Name and 510(k) Numbers: PIVIT A/B (K053656) Strattice (K070560) HydroCoat Mesh (K090271) Device Description: PIVIT A/B ST is identical to the PIVIT A/B de… | 2006 |
| * | K070560 | LRTM Surgical MeshSummary page 1…PrVIT A/B ST Device Common/Classification Name: Polymeric Surgical Mesh Predicate Devices Name and 510(k) Numbers: PIVIT A/B (K053656) Strattice (K070560) HydroCoat Mesh (K090271) Device Description: PIVIT A/B ST is identical to the PIVIT A/B device cleared via K053656. This… | 2007 |
| * | K090271 | Hydrocoat Mesh Cleared while this submission was under review Summary page 1…ssification Name: Polymeric Surgical Mesh Predicate Devices Name and 510(k) Numbers: PIVIT A/B (K053656) Strattice (K070560) HydroCoat Mesh (K090271) Device Description: PIVIT A/B ST is identical to the PIVIT A/B device cleared via K053656. This filing is meant to provide for… | 2010 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 71 ancestors have a recall of any class.
- Of its descendants, K113229 (C.R. Bard, Inc., 2012) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K053656.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
PIVIT A/B ST is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired Surgical outcome. The resorbable polymer coating on the mesh contains the antimicrobial agents, rifampin and minocycline to help provide protection from microbial colonization of the device during surgical implantation.
PIVIT A/B ST is intended for single patient one-time use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093524 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093524: Pivit a/B ST and Pivit a/B ST-R.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093524
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026